成人接种不同剂量重组乙型肝炎疫苗(汉逊酵母)的免疫学效果评价  

Evaluation of the Immunogenicity of Adults with Different Dosage of Hepatitis B Vaccine Made by Recombinant Deoxyribonucleic Acid Techniques in Hansenula polymorpha Yeast

作　　者：王萍[1] 李艳萍[2] 韦琳[1] 农艺[2] 蓝剑[1] 杨兵华[1] 唐雪梅[1] 严志玲[1] 

机构地区：[1]柳州市疾病预防控制中心,广西壮族自治区柳州545007 [2]广西壮族自治区疾病预防控制中心,南宁530028

出　　处：《中国疫苗和免疫》2013年第5期448-450,共3页Chinese Journal of Vaccines and Immunization

基　　金：广西壮族自治区柳州市科学技术局计划课题"成人剂型20g重组乙型肝炎疫苗(汉逊酵母)免疫原性和安全性研究"(编号:2011J030204);广西壮族自治区卫生厅自筹经费科学研究课题"成人剂型20g重组乙型肝炎疫苗(汉逊酵母)免疫原性和安全性研究"(编号:Z2011268)

摘　　要：目的观察成人接种不同剂量重组乙型肝炎(乙肝)疫苗(汉逊酵母)(Hepatitis B Vaccine Made by Recombinant Deoxyribonucleic Acid Techniques inHansenrla PolymorphaYeast,HepB-HPY)的免疫学效果。方法选择无HepB接种史和接种禁忌证,实验室筛检乙肝病毒(Hepatitis B Virus,HBV)标志物乙肝病毒表面抗原(HBV Surface Antigen,HBsAg)、抗乙肝病毒表面抗原抗体(Antibody to HBsAg,Anti-HBs)、抗乙肝病毒核心抗原抗体均阴性,丙氨酸氨基转移酶正常,年龄≥15岁的在校学生1600人作为观察对象。采用随机、双盲、对照原则,将入选的观察对象分为两组,每组各800人,以0、1、6个月全程免疫程序,分别接种20微克(g)和10 g HepB-HPY,受试者在免疫前、全程免疫后第4周采集静脉血,检测Anti-HBs。结果20 g组和10 g组Anti-HBs阳性[≥10毫国际单位/毫升(mIU/ml)]率分别为99.41%和98.03%,Anti-HBs几何平均浓度(Geometric Mean Concentration,GMC)分别为1511.88mIU/ml和1398.32mIU/ml。结论成人接种20 g和10 g HepB-HPY的免疫学效果良好,接种20 g HepB-HPY免疫学效果更好。Objective To observe the immunological effect of adults with different doses of hepatitis B vaccine made by recombinant deoxyribonucleic acid techniques in hansenula polymorpha yeast （HepB-HPY）. Methods Selected 1600 students who were over 15 years of age and without hepatitis B vaccination history and eontraindications to vaccination as the object of observation, laboratory screening for hepatitis B virus （HBV）markers of HBV surface antigen （HBsAg）, antibody to HBsAg （Anti-HBs） and antibody to HBV core antigen were all negative, alanine aminotransferase were normal. All selected object of observation were divided into two groups by using random, double blind and the control principle, and each group has 800 people. One group was inoculated with 20tg of HepB-HPY and the other group was inoculated with 10g＇ s by following the 0,1,6 months schedule. Collected venous blood to detect Anti- HBs before immunization and 4 weeks after whole course vaccination. Results The positive rate of Anti- HBs for the group which was vaccinated 20tg HepB-HPY was 99.41% and the other one was 98.03%, the geometric mean concentration （GMC） of the two groups were 1511.88mlU/ml and 1398.32mlU/ml. Conclusion Vaccination of 20g and 10tg HepB-HPY has a good immunological effect in adult. It was suggested that 20tg recombinant hepatitis B vaccine （hansenula polmorpha） is better for adult.

关 键 词：成人 重组乙型肝炎疫苗(汉逊酵母) 随机对照临床试验 免疫学效果 

分 类 号：R186[医药卫生—流行病学]